Use of Non-randomised Evidence Alongside Randomised Trials in a Systematic Review of Endovascular Aneurysm Repair: Strengths and Limitations

TY - JOUR

T1 - Use of Non-randomised Evidence Alongside Randomised Trials in a Systematic Review of Endovascular Aneurysm Repair: Strengths and Limitations

AU - Chambers, D

AU - Fayter, D

AU - Paton, F

AU - Woolacott, N

PY - 2010/1

Y1 - 2010/1

N2 - Objective: To assess whether limitations of randomised controlled trials (RCTs) of endovascular aneurysm repair (EVAR) can be addressed by evidence from non-randomised studies.Design: Analysis of data from a systematic review.Methods: We conducted a review of EVAR versus open repair or non-surgical management of abdominal aortic aneurysms. In addition to RCTs, we included pre-specified registries of EVAR and open repair.Results: The six included RCTs randomised patients in 2003 and earlier. Of the three registries included, one contributed data on a large (>8000) sample of patients treated with newer generation EVAR devices and followed up for up to 8 years. However, treatment dates of these patients overlapped with those of the RCTs. The other registries were of limited usefulness. A large (>45,000) controlled observational study published while the review was in progress broadly supported the findings of RCTs comparing EVAR with open surgery. A comparison of outcomes across all studies did not support the hypothesis that the findings of the RCTs are no longer representative of clinical practice.Conclusions: Both randomised and non-randomised sources of evidence have strengths and weaknesses for assessing the effectiveness of EVAR. Further research should explore the optimum use of registry data, including patient-Level analyses. Crown Copyright (C) 2009 Published by Elsevier Ltd on behalf of European Society for Vascular Surgery. All rights reserved.

AB - Objective: To assess whether limitations of randomised controlled trials (RCTs) of endovascular aneurysm repair (EVAR) can be addressed by evidence from non-randomised studies.Design: Analysis of data from a systematic review.Methods: We conducted a review of EVAR versus open repair or non-surgical management of abdominal aortic aneurysms. In addition to RCTs, we included pre-specified registries of EVAR and open repair.Results: The six included RCTs randomised patients in 2003 and earlier. Of the three registries included, one contributed data on a large (>8000) sample of patients treated with newer generation EVAR devices and followed up for up to 8 years. However, treatment dates of these patients overlapped with those of the RCTs. The other registries were of limited usefulness. A large (>45,000) controlled observational study published while the review was in progress broadly supported the findings of RCTs comparing EVAR with open surgery. A comparison of outcomes across all studies did not support the hypothesis that the findings of the RCTs are no longer representative of clinical practice.Conclusions: Both randomised and non-randomised sources of evidence have strengths and weaknesses for assessing the effectiveness of EVAR. Further research should explore the optimum use of registry data, including patient-Level analyses. Crown Copyright (C) 2009 Published by Elsevier Ltd on behalf of European Society for Vascular Surgery. All rights reserved.

UR - http://www.scopus.com/inward/record.url?scp=73749086405&partnerID=8YFLogxK

U2 - 10.1016/j.ejvs.2009.09.010

DO - 10.1016/j.ejvs.2009.09.010

M3 - Article

SN - 1078-5884

VL - 39

SP - 26

EP - 34

JO - European Journal of Vascular and Endovascular Surgery

JF - European Journal of Vascular and Endovascular Surgery

IS - 1

ER -